HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS

Официальное название

HemodynamIc eFfects of Lung Collapse and overdIstension in Patients With Moderate-to-seVEre Acute Respiratory Distress Syndrome: the HI-FIVE Physiologic Study

Обзор

The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention.

Вмешательства

• Другое Change in PEEP
  Patients will undergo a decremental PEEP trial to determine the crossing-point PEEP. Secondly, three PEEP levels (low collapse PEEP, low overdistention PEEP and crossing point between lung collapse and overdistention PEEP) will be compared in a randomized order with 30-minute steps

Первичные конечные точки

• Impact of lung collapse on cardiac output [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]
• Impact of lung collapse on pulmonary vascular resistance [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]
• Impact of lung overdistention on cardiac output [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]
• Impact of lung overdistention on pulmonary vascular resistance [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]

Вторичные конечные точки (9)

• Correlation between potential for lung recruitment and PEEP-induced changes in cardiac output [Срок оценки: Assessment at the end of each of the three 30 minute steps]
• Correlation between potential for lung recruitment and PEEP-induced changes in pulmonary vascular resistance [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]
• PEEP-induced effects on cardiac output in cardiac preload responsive vs. nonresponsive patients [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]
• PEEP-induced effects on pulmonary vascular resistance in cardiac preload responsive vs. nonresponsive patients [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]
• Relationship between transpulmonary pressures and central venous pressure variations [Срок оценки: At the end of each of the three 30 minute steps]
• Lung hysteresis [Срок оценки: At the end of each of the three 30 minute steps]
• Lung aeration distribution [Срок оценки: At the end of each of the three 30 minute steps]
• Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in pulmonary vascular resistance [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]
• Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in cardiac output [Срок оценки: Assesment performed at the end of each of the three 30 minute steps]

Критерии участия

Критерии включения

• acute respiratory failure with onset < 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock;
• bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses;
• pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities not primarily attributable to atelectasis;
• PaO2/FiO2 ratio ≤ 200 during invasive controlled mechanical ventilation;

Критерии исключения

• age <18 years;
• pregnancy;
• signs of barotrauma or documented pneumothorax;
• severe tachycardia (HR > 120 bpm) and severe lacticaemia (lac > 4 mmol/L)
• pre-existing decompensated heart failure (NYHA class 3-4 and/or documented left ventricular ejection fraction < 35%);
• contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker);
• intubation as a result of an acute exacerbation of chronic pulmonary disease;
• contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A.Gemelli IRCCS — Rome

Идентификаторы

NCT: NCT07423520 · 7795

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗